Neuren Media and Analyst Coverage, page-1208

I see, thanks for the correction. Yes I assumed it was our very own Gerry Zhao.

Separately, I recently learned that exclusivity periods can be granted for each orphan indication. This caught me by complete surprise, having been invested for over a decade in biotech stocks it was long assumed by myself and a group of fellow investors that a one-off exclusivity period was granted per drug. Clinuvel recently announced two orphan designations: xeroderma pigmentosum and variegate porphyria. In both press releases they stated the designation granted an exclusivity period if the indication was approved. After looking into it further, seperate exclusivity periods can indeed be granted for each orphan designated indication (This applies to both the US and Europe). Whether this grants exclusivity to the indication or just for the chemical composition itself is a contentious issue in the US: a company (Catalyst) sued the FDA when they granted approval to another company's drug a few months after Catalyst's drug was approved in the same indication. Catalyst won on appeal, but the FDA have said they will keep interpreting the statute as being chemical specific and not fencing off the indication entirely to other drugs for the exclusivity period.

I don't think that's an issue for NNZ-2591, it's unique. But I think seperate exclusivity periods enhances the value proposition of 2591 where generics are pushed further back from entering the market (I believe the industry term is called "salami slicing" whereby drug companies seek to extend exclusivity through additional orphan designations and other tactics).